MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NEXEL TOTAL ELBOW T-HANDLE; EXTREMITY INSTRUMENT

Catalog Number 00840100200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.Received, but not yet evaluated.

Event Description

It is reported the t-handle was damaged while hammering.Metal shavings came off the device.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Hardness and dimensions taken are within specification.The handle has heavy gouges.Review of the receiving inspection report did not find any deviations or anomalies.The complainant described burr's as metal shavings.The t-handle was manufactured on nov 15, 2013 and therefore has a potential field age of 2 years 4 months.The frequency of use of the device is unknown.This device is used for treatment.The strike marks confirms that the device has been extensively used.The instructions for use included with the device states, ¿if damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for a replacement.¿ a definite root cause cannot be determined with the information provided.

• Brand Name: ZIMMER NEXEL TOTAL ELBOW T-HANDLE
• Type of Device: EXTREMITY INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6042080
• MDR Text Key: 57918321
• Report Number: 0001822565-2016-03805
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00840100200
• Device Lot Number: 62535064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1